Use caution Medical device recall · FDA · Published December 22, 2021

Synthes Universal Chuck Recall: Top Cap May Detach During Surgery

Synthes recalls Universal Chuck instrument handles used in orthopedic surgery due to risk of top cap detaching if jammed, causing surgical delays or infection.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0634-2022Medical device Synthes ›

Use caution until it’s fixed

Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.

Take action

Contact the company

Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986

✎ GovInfoNow plain-language explainer

Synthes is recalling Universal Chuck instrument handles used in orthopedic surgery. If the device jams and the user tries to free it, the top cap may loosen and detach, potentially causing surgical delays or infections. Read more at govinfonow.com/recall/61377-synthes-universal-chuck-recall-top-cap-may-detach-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/61377-synthes-universal-chuck-recall-top-cap-may-detach-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0634-2022

Cite this page

“Synthes Universal Chuck Recall: Top Cap May Detach During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61377-synthes-universal-chuck-recall-top-cap-may-detach-during-surgery. Based on FDA recall #Z-0634-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0634-2022%22&limit=1).

The FDA announced on Dec. 22, 2021, that Synthes (USA) Products LLC is recalling Universal Chuck instrument handles due to a hazard of loosening top caps and detached ball bearings. The agency issued recall number Z-0634-2022 for the Class II device.

How to tell if you have it

Brand: Synthes
Product: Universal Chuck (Instrument Handle)
Product No.: 03.043.001
Lot/Serial Nos.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201, 21869701, 21983904, 21995301
GTIN: 10886982297372
UPC: 10886982297372

The hazard

According to the FDA, the top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device. Internal ball bearings may fall out onto the surgical field, causing surgical delay or, if not recovered, adverse tissue reaction and infection.

Context

GovInfoNow's records show Synthes (USA) Products LLC has 19 other recalls on record since July 21, 2017. Other recent recalls of similar products include the Synthes Stardrive Screwdrivers Recall (April 25, 2024), the Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025), and the Zimmer Off-Axis Shoulder System Recall (May 20, 2026).

How to tell if you have this one

Check for product numbers: 03.043.001; lots/serials: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201, 21869701, 21983904, 21995301. The Universal Chuck is used with specific orthopedic systems like TN-ADVANCED Tibial Nailing System.

Brand
Synthes
Product
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Numbers
Verify your Universal Chuck has product number 03.043.001 and one of the listed lot/serial numbers.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 56 days after the firm started it.

Dec 22, 2021Firm started the recall
Feb 10, 2022FDA classified it Class II
Feb 16, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61377-synthes-universal-chuck-recall-top-cap-may-detach-during-surgery">Synthes Universal Chuck Recall: Top Cap May Detach During Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0634-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0634-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.